ONE NEUROLOGIST'S OPINION REGARDING STROKE TREATMENT AND PREVENTION

Entries from May 2006

A physician puts into context the data that implicates Vioxx and other COX-2 inhibitors as causing strokes and heart attacks.

Summary:

(As found in the May, 2006 issue [Volume 9;No 5] of CNS News)

In this article, Dr. Ivan Oransky briefly reviewed the data regarding use of Vioxx (rofecoxib) and stroke and heart attack risk. The first study which found a possible association between Vioxx use and heart attack risk came from the VIGOR trial (Vioxx Gastrointestinal Outcome Research, published 2000). In this study, those taking Vioxx had a 0.4% risk of stroke. Those taking another anti-inflammatory medication (naproxen) had only a 0.1% risk; which was found to be a statistically significant difference. It was unclear, though, whether this represented a protective effect of naproxen, or a detrimental effect of Vioxx. Later studies, involving use of Vioxx to prevent colonic polyps, were reviewed carefully with regard to increased risk of heart attacks and strokes. In one such study, a thrombotic event (generally an ischemic stroke or heart attack) occurred at a rate of 1.5 events per 100 patient-years in the Vioxx group and at a rate of 0.78 events per 100 patient-years in the placebo group. This represented essentially a doubling of the risk of an event in those taking Vioxx. The author puts this information into more meaningful terms as follows: if you were of similar risk as those who were enrolled in the study, and did not take Vioxx, your risk would be 16% of an ischemic stroke or heart attack over 20 years. If you took Vioxx over those 20 years, your risk of having an ischemic stroke or heart attack in that time would increase to 30%.

Interestingly, referring to a separate study, the author also notes that Celebrex (celecoxib, a product still on the market) had similar effects. There was a 1% risk of thrombotic events in those on placebo and a 4% risk in those taking Celebrex (400mg twice a day). The risk was less dramatic in those taking Celebrex at only 200mg twice a day (2.3%).

Finally, a study analyzing effects of placebo versus valdecoxib (Bextra) versus parecobix (a pro-drug of valdecoxib) was conducted for the treatment of pain in patients who had just undergone coronary bypass grafting. In this group, there was a 0.5% risk of a cardiovascular event in the placebo group, but a 2.0% risk in the groups given drug.

Commentary:

This was a great, short article, attempting to state clearly the risks of these medications. Clearly Bextra, Celebrex, and Vioxx can all increase the risk of an ischemic stroke or heart attack. Three variables, though, must be considered in anyone who may be considering taking these medications. The first is baseline risk. A person with known coronary heart disease, history of a stroke, atherosclerosis in other regions of the body, diabetes, high blood pressure, or elevated cholesterol will have a high baseline risk of a stroke or heart attack. In these folks, a doubling of the risk (on a COX-2) may result in a much higher risk of an event over time. On the other hand, a person without such a high risk (the athelete with low cholesterol in his or her 20's) may experience the doubling of his baseline insignificant risk: which would still likely be an insignificant risk.

The second variable to consider is time. Taking these medications for 20 years (for chronic arthitis, for example) will be much more of a risk than taking them for three days (to treat an acute pain).

A final important variable is the degree of one's pain and what other options are available. Patients who cannot tolerate other medications, and who have severe pain from rheumatoid arthritis, may be willing to assume the longterm risks of the COX-2 inhibitors, in order to improve their quality of life.

It is with reference to these points that I feel all of these medications should still be available to patients. (Vioxx and Bextra are off the market, Celebrex remains on the market). It should be up to patients, in consultation with their physicians, whether or not to use these medications, determining for themselves whether the benefits outweigh the risks. But the FDA, unfortunately, adopts a one-size fits all approach to this issue - forever erring on the side of caution regarding potential risks. Also, given the current medicolegal climate, drug companies probably do not feel they can keep such products on the market, no matter how informed the patients and physicians are of potential risks.

Stroke Doc

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